Evaluation of Stroke Patient Screening

Stroke, Acute Clinical Trial

Official title:

Evaluation of Stroke Patient Screening in an Acute Stroke Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633422
• Other study ID #: Req-2017-00844
• Status: Completed
• Start date: September 25, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: January 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background and Rationale:

Traditionally, stroke rehabilitation studies have been performed in stroke patients beyond the first one to three months poststroke [Stinear et al. 2013; Veerbeek et al. 2014]. Acknowledging that early stroke rehabilitation should be initiated soon after stroke onset to optimize stroke outcomes, it is has been stressed that stroke rehabilitation trials should be initiated within the first month [Stinear 2013].

Early stroke rehabilitation trials face difficulties regarding patient recruitment with corresponding low enrollment rates [AVERT 2015; Winters 2015]. Explanations are for example priority given to (sub)acute medical interventions, highly dynamic situation at a stroke unit, and a more rapid change in patients' abilities when compared to patients in later stages poststroke. With the low enrollment rates (~7%), the generalizability of study results is questionable.

Participant screening methods and procedures for research eligibility are part of the patient selection and recruitment process in clinical trials. However, no information is available regarding screening procedures and methods for these early initiated stroke rehabilitation trials, including reasons for not enrolling patients. This knowledge is essential to improve screening procedures and methods, in order to optimize patient enrollment and with that, increase the generalizability of study results.

Objective:

The objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research.

Study Design:

Observational study

Description:

Objective:

The objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research in the Department of Neurology, University Hospital Zurich.

Outcome:

Enrollment rates (defined as the number of patients enrolled per month of recruitment), reasons for non-enrollment, and estimated costs for screening for early stroke rehabilitation studies.

Study Design:

Observational study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 845
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First-ever unilateral ischemic stroke <48 hours, confirmed by MRI-DWI and/or CT

• Age 18 years or older

• Able to follow one-staged commands

• NIHSS arm score =1

• Informed consent after participants' information

Exclusion Criteria:

• Modified Rankin Scale score >2 before stroke

• Neurological or other diseases affecting the upper limb(s) before stroke

• Intravenous line in the upper limb(s) which limits assessment

• Contra-indications on ethical grounds

• Expected or known non-compliance to participate in the observational study, severe drug or/and alcohol abuse

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
Switzerland	Zürcher RehaZentrum Wald	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16. Erratum in: Lancet. 2015 Jul 4;386(9988):30. Erratum in: Lancet. 2017 May 13;389(10082):1884. — View Citation

Held JPO, van Duinen J, Luft AR, Veerbeek JM. Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study. Front Neurol. 2019 Jul 2;10:683. doi: 10.3389/fneur.2019.00683. eCollection 2019. — View Citation

Stinear C, Ackerley S, Byblow W. Rehabilitation is initiated early after stroke, but most motor rehabilitation trials are not: a systematic review. Stroke. 2013 Jul;44(7):2039-45. doi: 10.1161/STROKEAHA.113.000968. Epub 2013 May 28. Review. — View Citation

Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014. Review. — View Citation

Winters C, van Wegen EE, Daffertshofer A, Kwakkel G. Generalizability of the Proportional Recovery Model for the Upper Extremity After an Ischemic Stroke. Neurorehabil Neural Repair. 2015 Aug;29(7):614-22. doi: 10.1177/1545968314562115. Epub 2014 Dec 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reasons why participants are not eligible for an early rehabilitation trial	The reasons for non-enrollment will be measured by counting, based on the inclusion and exclusion criteria of the aRISE study	1 Day
Secondary	Enrolment rate	Defined as the number of patients enrolled per month of screening	1 Month
Secondary	Estimated personnel expenses in Swiss Francs for screening	Swiss Francs associated with screening in the hospital	1 Month